Controlled impotence treatment

ABSTRACT

A male sexual impotence treatment apparatus comprises an operable restriction device ( 56 ) implanted in a patient and engaging the penile tissue ( 58 ) or the prolongation thereof to form a restrictable blood flow passageway through which blood flow leaves the penis. The restriction device is operable by an implanted operation device ( 60 ) to change the restriction of the blood flow passageway. A control device ( 62  and  64 ) is provided for controlling a source of energy, which may or may not be implanted, from outside the patient&#39;s body, to release energy for use in connection with the operation of the restriction device, i.e. to power the operation device. The patient uses the control device to restrict the blood flow leaving the penis to achieve erection.

The present invention relates to a male sexual impotence treatmentapparatus, comprising an operable restriction device implantable in apatient for engaging the penile tissue or the prolongation thereof toform a restricted blood flow passageway through which blood flow leavesthe penis. The restriction device is operable to restrict the passagewayto provide erection. The expression “penile tissue or the prolongationthereof” should be understood to mean the penile tissue extended insidethe human body and following the pathway of the blood flow leaving thepenis i.e. one or more exit veins from the penis, the corpus cavernosum,crura or the prolongation thereof.

Male sexual impotence is a widespread problem. Many different solutionsto this problem have been tried. A solution currently practised is toimplant a hydraulic inflatable/contractable silicon prosthesis in thepatient's penile tissue. In fluid connection with this prosthesis is areservoir implanted in the scrotum. By manual pumping action theprosthesis is filled with fluid from the reservoir to effect errectpenile condition or is emptied of fluid, which returns to the reservoir,to effect flaccid penile condition. However, there are several more orless severe disadvantages of this solution. Above all, the penis is moreor less damaged by the operation and it is practically impossible toreverse the operation. Another disadvantage is that rather strong forcesact against this implanted prosthesis resulting in a significant risk ofthe prosthesis being broken.

Another solution to achieve erection is to restrict the blood flowleaving the penis. For example, U.S. Pat. Nos. 4,829,990, 4,958,630 and5,048,511 disclose two hydraulically operated inflatable cuffs wrappedaround respective crura or veins. A disadvantage of such a solution isthat it involves complicated surgery. Another example on this solutionis U.S. Pat. No. 4,828,544, which discloses an artificial fistula systemsurgically implanted and providing a primary fistula between the femoralartery and the femoral vein and a secondary fistula for leading bloodfrom the the primary fistula to the penis. An inflatable balloon engagesthe primary fistula between the secondary fistula and the vein. Theballoon is in fluid connection with a manually compressible reservoirimplanted in the scrotum. Again, implantation of this artifical fistulasystem requires delicate surgery.

Yet another solution is to inject a substance in the penile vein systemto achieve erection. However, injections are painful and complicated forthe patient.

The object of the present invention to provide a simple male sexualimpotence treatment apparatus which is conveniently controlled by thepatient.

This object is obtained by an apparatus of the kind described initially,which is characterised in that a source of energy is provided, and acontrol device operable from outside the patient's body is provided forcontrolling the source of energy to release energy for use in connectionwith the operation of the restriction device, when the restrictiondevice is implanted.

As a result, the advantage is achieved that the restriction device carbe operated without need for touching subcutaneously implantedcomponents of the apparatus, when the restriction device shall beadjusted. Furthermore, the apparatus of the invention provides simpleand effective control of the energy supplied to implanted components ofthe apparatus which ensures an extended and reliable functionality ofthe apparatus, possibly for the rest of the patient's natural life, andat least many years.

The restriction device may be implanted in the base of the patient'spenis or the prolongation thereof and preferably may engage the corpuscavernosum, crura or the prolongation thereof of the penis. However,there are several alternative positions of the restriction device thatgive more or less satisfactory restriction of the blood flow leaving thepenis. Thus, as a first alternative the restriction member may extendaround both corpora cavernosa or crura of the penis as a single unit. Asa second alternative the restriction device may comprise two elongatedrestriction members extending around the respective corpora cavernosa orcrura. As a third alternative the elongated restriction member mayencircle one or more of the penile exit veins. As a fourth alternativethe restriction device may comprise several restriction membersextending around the respective penile exit veins.

The restriction device preferably controls the size of thecross-sectional area of the passageway through which blood flow leavesthe penis, which gives the advantage that the patient is enabled toadjust the restriction device to achieve the desired erection withoutfeeling pain. This advantage should not be underestimated, because fineadjustments to decrease the cross-sectional area of the passageway, willallow maximal erection with a minimum of restriction. The control devicemay also control the restriction device. The control device may comprisean internal control unit, preferably including a microprocessor,implanted in the patient for controlling the restriction device. Thecontrol device may further comprise an external control unit outside thepatient's body, wherein the internal control unit is programmable by theexternal control unit, for example for controlling the restrictiondevice aver a short period of time. Alternatively, the internal controlunit may control the restriction device over time in accordance with anactivity schedule program, which may be adapted to the patient's needs.For example to avoid an abnormally high pressure against the humantissue.

Conveniently, the external control unit may load the internal controlunit with data in accordance with a loading mode only authorized for adoctor. For specialized controls of the restriction device, the externalcontrol unit may control the internal control unit in accordance with adoctor mode only authorized for the doctor. For simple controls of therestriction device, the external control unit may control the internalcontrol unit in accordance with a patient mode permitted for thepatient. Thus, by using the external control unit in accordance withdifferent modes it is possible to have certains functions of therestriction device controlled by the patient and other more advancedfunctions controlled by the doctor, which enables a flexiblepost-operation treatment of the patient.

The control device may be adapted to control the source of energy torelease energy, for instance to intermittently release energy in theform of a train of energy pulses, for direct use in connection with theoperation of the restriction device. In accordance with a suitableembodiment the control device controls the source of energy to releaseelectric energy, and the apparatus further comprises an implantablecapacitor for producing the train of energy pulses from the releasedenergy. In this case the term “direct” is used to mean, on one hand,that the released energy is used while it is being released by thecontrol device, on the other hand, that the released energy may besomewhat delayed, in the order of seconds, by for instance an energystabiliser before being used in connection with the operation of therestriction device. The restriction device may be operable innon-manual, a non-magnetic or non-mechanical manner by use of thereleased energy.

In accordance with a preferred embodiment of the invention, theapparatus comprises implantable electrical components including at leastone, or only one single voltage level guard and a capacitor oraccumulator, wherein the charge and discharge of the capacitor oraccumulator is controlled by use of the voltage level guard. As aresult, there is no need for any implanted current detector and/orcharge level detector for the control of the capacitor, which makes theapparatus simple and reliable.

Generally, the apparatus further comprises an operation deviceimplantable in the patient for operating the restriction device, whereinthe control device controls the operation device to operate therestriction device. The control device may directly power the operationdevice with energy released from the source of energy and/or power otherimplantable energy consuming components of the apparatus. In this casethe term “directly” is used to mean, on one hand, that the operationdevice is powered with released energy while the latter is beingreleased by the control device, on the other hand, that the releasedenergy may be somewhat delayed, in the order of seconds, by for instancean energy stabiliser before powering the operation device. The advantageof directly using energy as it is released is that the apparatus can beof a very simple design and the few components involved makes theapparatus reliable.

The restriction device may be non-inflatable, i.e. with no hydraulicfluid involved for the adjustments of the restriction device. Thiseliminates problems with fluid leaking from the restriction device.

The operation device may comprise hydraulic means and at least one valvefor controlling a fluid flow in the hydraulic means. The control devicemay suitably comprise a wireless remote control for controlling thevalve. The restriction device may comprise hydraulic means and theoperation device may comprise a reservoir forming a fluid chamber with avariable volume connected to the hydraulic means. The operation devicemay distribute fluid from the chamber to the hydraulic means byreduction of the volume of the chamber and withdraw fluid from thehydraulic means to the chamber by expansion of the volume of thechamber.

In accordance with a first main aspect of the invention, the source ofenergy is external to the patient's body and the control device controlsthe source of energy to release wireless energy. The external source ofenergy may be of any conceivable kind, such as a nuclear source ofenergy or a chemical source of energy.

An energy storage device, preferably an electric accumulator, may beimplanted in the patient for storing the wireless energy released fromthe external source of energy. The electric accumulator may comprise atleast one capacitor or at least one rechargeable battery, or acombination of at least one capacitor and at least one rechargeablebattery. Alternatively, a battery may be implanted in the patient forsupplying electric energy to implanted electric energy consumingcomponents of the apparatus, in addition to the supply of wirelessenergy. Where the control device comprises an implantable control unitthe electronic circuit thereof and the restriction device may bedirectly powered with transformed wireless energy, or energy from eitherthe implanted energy storage device or battery.

In accordance with a second main aspect of the invention, the wirelessenergy is directly used for operation of the restriction device, i.e.the restriction device is operated as the wireless energy is releasedfrom the external source of energy by the control device. In this casethe term “directly” is used to mean, on one hand, that the restrictiondevice is promptly operated by using the released energy without firststoring the latter, on the other hand, that the released energy maybesomewhat delayed, in the order of seconds, by for instance an energystabiliser before being used for the operation of the restrictiondevice. As a result, a very simple control of the restriction device isachieved and there are only a few implanted components of the apparatus.For example, there is no implanted source of energy, such as a battery,nor any implanted complicated signal control system. This gives theadvantage that the apparatus will be extremely reliable.

Generally, the control device controls and directly or indirectly powersthe operation device with wireless energy released from the source ofenergy and/or powers other implanted energy consuming components of theapparatus.

In a first particular embodiment in accordance with the first and secondmain aspects of the invention, the operation device comprises a motor,preferably an electric motor which may have electrically conductiveparts made of plastics. The motor may include a rotary motor, whereinthe control device is adapted to control the rotary motor to rotate adesired number of revolutions. Alternatively, the motor may include alinear motor, or a hydraulic or pneumatic fluid motor, wherein thecontrol device is adapted to control the fluid flow through the fluidmotor. Motors currently available on the market are getting smaller andsmaller. Furthermore, there is a great variety of control methods andminiaturized control equipment available. For example, a numberof,revolutions of a rotary motor may be analyzed by a Hall-element justa few mm in size.

In a second particular embodiment, in accordance with the first andsecond main aspects of the invention, the control device is adapted toshift polarity of the released energy to reverse the operation device.The operation device may suitably comprise an electric motor and thereleased energy may comprise electric energy.

In a third particular embodiment in accordance with the first and secondmain aspects of the invention, the restriction device is operable toperform a reversible function and there is a reversing deviceimplantable in the patient for reversing the function performed by therestriction device. Such a reversing function preferably involvesenlarging and restricting the blood flow passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

In accordance with the third particular embodiment, the operation devicepreferably comprises a motor, wherein the reversing device reverses themotor.

In a fourth particular embodiment in accordance with the first andsecond main aspects of the invention, the restriction device compriseshydraulic means, for example including an expansible/contractible cavityfor fluid. Preferably, the operation device is adapted to conducthydraulic fluid in the hydraulic means, and comprises a motor, avalveless fluid conduit connected to the hydraulic means of therestriction device, and a reservoir for fluid, wherein the reservoirforms part of the conduit. The operation device suitably comprises apump operated by the motor. All of the hydraulic components involved arepreferably deviod of any non-return valve. This is of great advantage,because with valves involved there is always a risk of malfunction dueto inproperly working valves, especially when long time periods passbetween valve operations. The reservoir may form a fluid chamber with avariable volume, and the pump may distribute fluid from the chamber tothe hydraulic means of the restriction device by reduction of the volumeof the chamber and withdraw fluid from the hydraulic means to thechamber by expansion of the volume of the chamber.

In accordance with a third main aspect of the invention, the source ofenergy is implantable in the patient. Thus, when the source of energy isimplanted in a patient the control device controls it from outside thepatient's body to release energy. This solution is advantageous forembodiments of the apparatus that have a relatively high consumption ofenergy which cannot be satisfied by direct supply of wireless energy.

The implantable source of energy may comprise an accumulator, preferablyan electric source of energy, such as a battery having a lifetime of atleast 10 years.

In accordance with a fourth main aspect of the invention, the apparatuscomprises a switch implanted in the patient for directly or indirectlyswitching the operation of the restriction device and an internal sourceof energy, such as a battery, implanted in the patient for supplyingenergy for the operation of the restriction device, wherein the switchdirectly or indirectly affects the supply of energy from the internalsource of energy. This solution is advantageous for embodiments of theapparatus that have a relatively high energy consumption which cannot bemet by direct supply of wireless energy.

In a first particular embodiment in accordance with the fourth mainaspect of the invention, the switch switches between an off mode, inwhich the internal source of energy is not in use, and an on mode, inwhich the internal source of energy supplies energy for the operation ofthe restriction device. In this case, the switch is convenientlyoperated by the wireless energy released from the external source ofenergy to switch between the on and off modes. The control device,preferably comprising a wireless remote control, may control theexternal source of energy to release the wireless energy. The advantageof this embodiment is that the lifetime of the implanted source ofenergy, such as a battery, can be significantly prolonged, since theimplanted source of energy does not supply energy when the switch is inits off mode.

In a second particular embodiment in accordance with the fourth mainaspect of the invention, the control device comprises a wireless remotecontrol for controlling the internal source of energy. In this case, theswitch is operable by the wireless energy from the external source ofenergy to switch between an off mode, in which the internal source ofenergy and remote control are not in use, and a standby mode, in whichthe remote control is permitted to control the internal source of energyto supply energy for the operation of the restriction device.

In a third particular embodiment in accordance with the fourth mainaspect of the invention, the apparatus further comprises an energytransforming device implanted in the patient for transforming thewireless energy into storable energy, wherein the internal source ofenergy is capable of storing the storable energy. The internal source ofenergy preferably comprises an electric accumulator, at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. In this case,the switch switches from an off mode, in which the internal source ofenergy is not in use, to an on mode, in which the internal source ofenergy supplies energy for the operation of the restriction device.

The control device, preferably comprising a wireless remote control, maycontrol the switch to switch between the on and off modes.

Alternatively, in this third particular embodiment an energy storagedevice may be implanted in the patient for storing the storable energyinstead of the internal source of energy, wherein the switch is operableby energy from the implanted energy storage device to switch between anoff mode, in which the internal source of energy is not in use, and anon mode, in which the internal source of energy supplies energy for theoperation of the restriction device. In this case, the control device(the wireless remote control) controls the energy storage device tooperate the switch.

The internal source of energy preferably comprises an electric source ofenergy, such as an accumulator or a battery having a lifetime of atleast 10 years. However, other kinds of sources are also conceivable,such as a nuclear source of energy or a chemical source of energy.

The above first, second, third and fourth particular embodimentsdescribed in connection with the first and second main aspects of theinvention are also applicable in accordance with the third main aspectof the invention, i.e. where the source of energy is to be implanted,and in accordance with the fourth main aspect of the invention, i.e.where the apparatus comprises an implantable switch.

All of the above embodiments may be combined with at least oneimplantable sensor for sensing at least one physical parameter of thepatient, wherein the control device may control the restriction devicein response to signals from the sensor. For example, the sensor maycomprise a pressure sensor for directly or indirectly sensing thepressure in the blood flow passageway. The expression “indirectlysensing the pressure in the blood flow passageway” should be understoodto encompass the cases where the sensor senses the pressure against therestriction device or human tissue of the patient. The pressure sensormay be any suitable known or conventional pressure sensor such as shownin U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267, 4,571,749, 4,407,296or 3,939,823; or an NPC-102 Medical Angioplasty Sensor. Where thecontrol device comprises an internal control unit to be implanted in thepatient, the internal control unit may suitably directly control therestriction device in response to signals from the sensor. In responseto signals from the sensor, for example pressure, the patient's positionor any other important physical parameter, the internal control unit maysend information thereon to outside the patient's body. The control unitmay also automatically control the restriction device in response tosignals from the sensor. For example, the control unit may control therestriction device to enlarge the blood flow passageway in response tothe sensor sensing an abnormally high pressure against the restrictiondevice.

Where the control device comprises an external control unit outside thepatient's body, the external control unit may, suitably directly,control the restriction device in response to signals from the sensor.The external control unit may store information on the physicalparameter sensed by the sensor and may be manually operated to controlthe restriction device based on the stored information. In addition,there may be at least one implantable sender for sending information onthe physical parameter sensed by the sensor.

An external data communicator may be provided outside the patient's bodyand an internal data communicator to be Implanted in the patient may beprovided for communicating with the external data communicator. Theinternal data communicator may feed data related to the patient, orrelated to the restriction device, back to the external datacommunicator. Alternatively or in combination, the external datacommunicator may feed data to the internal data communicator. Theinternal data communicator may suitably feed data related to at leastone physical signal of the patient.

Generally, the apparatus of the invention may comprise a switch to beimplanted in the patient for directly or indirectly switching the energyreleased from the source of energy. For example, the restriction devicemay be operable to steplessly control the restriction of the blood flowpassageway. A pressure sensor may be provided for directly or indirectlysensing the pressure in the blood flow passageway. The control devicemay control the restriction device in response to signals from thepressure sensor.

The apparatus may comprise an implantable energy transforming device,wherein the control device releases electric energy and the energytransforming device transforms the electric energy into kinetic energyfor, preferably direct, operation of the restriction device. Suitably,an implantable stabiliser, such as a capacitor or a rechargeableaccumulator, or the like, may be provided for stabilising the electricenergy released by the control device. In addition, the control devicemay control the source of energy to release energy for a determined timeperiod or in a determined number of energy pulses. Finally, therestriction device may be non-inflatable.

All of the above embodiments are preferably remote controlled. Thus, thecontrol device advantageously comprises a wireless remote controltransmitting at least one wireless control signal controlling therestriction device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need.

The wireless remote control may be capable of obtaining information onthe condition of the restriction device and of controlling therestriction device in response to the information. Also, The remotecontrol may be capable of sending information related to the restrictiondevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implantable in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplantable in the patient.

The remote control may transmit a carrier signal for carrying thecontrol signal, wherein the carrier signal is frequency, amplitude orfrequency and amplitude modulated and is digital, analog or digital andanalog. Also the control signal used with the carrier signal may befrequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analog, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analog control signal. For example, use of an analog carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

In all of the above solutions, the control device advantageouslyreleases energy from the source of energy in a non-invasive, magnetic,non-magnetic, mechanical or non-mechanical manner.

The control device may release magnetic, electromagnetic, kinetic, sonicor thermal energy, or non-magnetic, non-sonic, non-thermal,non-electromagnetic or non-kinetic energy.

The control device may be activated in a manual or non-manual manner tocontrol the source of energy to release energy.

The operation device may be powered by magnetic energy, non-magneticenergy, electromagnetic energy, non-electromagnetic energy, kineticenergy, non-kinetic energy, thermal energy or non-thermal energy.However, preferably the operation device comprises an electricaloperation device.

Typically the apparatus of the invention comprises an adjustment devicefor adjusting the restriction device to change the restriction of theblood flow passageway. The adjustment device may be adapted tomechanically adjust the restriction device. Alternatively, theadjustment device may be adapted to hydraulically adjust the restrictiondevice by using hydraulic means which is devoid of hydraulic fluid ofthe kind having a viscosity that substantially increases when exposed toheat or a magnetic field, i.e. the hydraulic fluid would not become moreviscous when exposed to heat or influenced by magnetic forces.

The above-presented embodiments of the invention may be modified inaccordance with the following suggestions. The released energy maycomprise electric energy and implantable capacitor having a capacityless than 0.1 μF may be provided for producing the above-mentioned trainof energy pulses.

An implantable motor or pump may be provided for operating therestriction device, wherein the control device is adapted to control thesource of energy to directly power the motor or pump with the releasedenergy. Specifically, the control device may be adapted to releasewireless energy in the form of a magnetic field or electromagnetic waves(excluding radio waves) for direct power of the motor or pump, as thewireless energy is being released. Where a pump is used it preferably isnot a plunger type of pump.

Generally, the wireless energy comprises a signal.

The apparatus may further comprise implantable energy transformingdevice for transforming wireless energy directly or indirectly intoenergy different than the wireless energy, for operation of therestriction device. For example, the motor or pump may be powered by thetransformed energy.

The energy transforming device may transform the wireless energy in theform of sound waves, preferably directly, into electric energy foroperation of the restriction device. The energy transforming device maycomprise a capacitor adapted to produce electric pulses from thetransformed electric energy.

The motor mentioned in the present specification may also be directlypowered with wirelessly transmitted electromagnetic or magnetic energyin the form of signals, as the energy is transmitted. Furthermore, allthe various functions of the motor and associated components describedin the present specification may be used where applicable.

Generally, the restriction device advantageously is embedded in a softor gel-like material, such as a silicone material having hardness lessthan 20 Shore.

Of course, the restriction device preferably is adjustable in anon-manual manner.

All the above described various components, such as the motor, pump andcapacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable.

All the various ways of transferring energy and controlling the energypresented in the present specification may be practised by using all ofthe various components and solutions described.

The present invention also provides a method of treating an impotentmale patient, comprising: (a) surgically implanting in the male patientan operable restriction device engaging the penile tissue or theprolongation thereof to form a restrictable passageway for blood flowleaving the penis. (b) Providing a source of energy. (c) Controlling thesource of energy to release energy for use in connection with theoperation of the restriction device.

Steps (b) and (c) may further comprise providing a source of energyexternal to the patient's body and controlling the external source ofenergy from outside the patient's body to release wireless energy foruse in connection with the operation of the restriction device.

The method may further comprise (d) implanting in the patient anoperation device which can adjust the restrictable passageway inresponse to supplied energy, and (f) using the released wireless energyto operate the implanted operation device to enlarge and restrict,respectively, the passageway.

In accordance with an alternative method, there is provided a method oftreating an impotent male patient, comprising the steps of placing atleast two laparascopical trocars in the patient's body, inserting adissecting tool through the trocars and dissecting an area of the peniletissue or the prolongation thereof, placing an operable restrictiondevice in the dissected area in engagement with the penile tissue or theprolongation thereof to form a restrictable passageway for the bloodflow leaving the penis, providing a source of energy outside or insidethe male patient's body, controlling the source of energy from outsidethe patient's body to release energy, which may comprise wireless energywhere the source of energy is external to the patient's body, and usingthe released energy in connection with the operation of the restrictiondevice.

In accordance with another alternative method, there is provided amethod of treating an impotent male patient, comprising the steps ofplacing at least two laparascopical trocars in the male patient's body,inserting a dissecting tool through the trocars and dissecting an areaof the penile tissue or the prolongation thereof, implanting an operablerestriction device in the dissected area in engagement with the peniletissue or the prolongation thereof to form a restrictable passageway forblood flow leaving the penis, implanting an energy transforming device,providing an external source of energy, controlling the external sourceof energy to release wireless energy, and transforming the wirelessenergy by the energy transforming device into energy different than thewireless energy for use in connection with the operation of therestriction device. This method may further comprise implanting astabiliser in the patient's body to stabilize the energy transferred bythe energy transforming device.

It is the primary object of the present invention to provide a simpleyet effective apparatus for treating male sexual impotence. This andother objects of the invention will become clear from an inspection ofthe detailed description of the invention and from the appended claims.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIGS. 1 to 6 are schematic block diagrams illustrating six embodiments,respectively, of the invention, in which wireless energy released froman external source of energy is used for direct operation of arestriction device engaging the penile tissue of a patient;

FIGS. 7 to 10 are schematic block diagrams illustrating fourembodiments, respectively, of the invention, in which energy is releasedfrom an implanted source of energy;

FIGS. 11 to 15 are schematic block diagrams illustrating fiveembodiments, respectively, of the invention, in which a switch isimplanted in the patient for directly or indirectly switching theoperation of the restriction device;

FIG. 16 is a schematic block diagram illustrating conceivablecombinations of implantable components for achieving variouscommunication options;

FIG. 17 illustrates the apparatus in accordance with the inventionimplanted in a patient;

FIG. 18 is a block diagram illustrating remote control components of anembodiment of the invention; and

FIG. 19 is a schematic view of exemplary circuitry used for thecomponents of the block diagram of FIG. 18.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIG. 1 schematically shows an embodiment of the male sexual impotencetreatment apparatus of the invention having some parts implanted in apatient and other parts located outside the patient's body. Thus, inFIG. 1 all parts placed to the right of the patient's skin 2 areimplanted and all parts placed to the left of the skin 2 are locatedoutside the patient's body.

The apparatus of FIG. 1 comprises an implanted operable restrictiondevice 4, which engages the patient's penile tissue to form arestrictable blood flow passageway for blood flow leaving the penis. Therestriction device 4 is capable of performing a reversible function,i.e. to enlarge and reduce the cross-sectional area of the restrictablepassageway, whereby the restriction device works as an artificialsphincter. An implanted control unit 6 controls the restriction device 4via a control line 8 to form an adequate size of the cross-sectionalarea of the restrictable passageway. An external control unit 10includes an external source of energy and a wireless remote controltransmitting a control signal generated by the external source ofenergy. The control signal is received by a signal receiver incorporatedin the implanted control unit 6, whereby the control unit 6 controls theimplanted restriction device 4 in response to the control signal. Theimplanted control unit 6 also uses energy from the control signal fordirectly operating the restriction device 4 via a power supply line 12,as the control signal is transmitted.

FIG. 2 shows an embodiment of the invention identical to that of FIG. 1,except that a reversing device in the form of a switch 14 operable byenergy also is implanted in the patient for reversing the restrictiondevice 4. The control unit n uses the switch 14 to reverse the functionperformed by the restriction device 4. More precisely, the externalcontrol unit 10 releases energy carried by a wireless signal and theimplanted control unit 6 transforms the wireless energy into a currentfor operating the switch When the control unit 6 shifts the polarity ofthe current the switch 14 reverses the function performed by therestriction device 4.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 1,except that an operation device in the form of a motor 16 also isimplanted in the patient. The implanted control unit 6 powers the motor16 with wireless energy released from the external source of energy ofthe external control unit 10. The implanted control unit 6 controls theoperation of the motor 16 in response to a control signal from theremote control of the external control unit 10.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 1,except that an assembly 16 including a Motor/pump unit 18 and a fluidreservoir 20 also is implanted in the patient. In this case therestriction device 4 is hydraulically operated, i.e. hydraulic fluid ispumped by the motor/pump unit 18 from the reservoir 20 through a conduit22 to the restriction device 4 to restrict the urine passageway, andhydraulic fluid is pumped by the motor/pump unit 18 back from therestriction device 4 to the reservoir 20 to enlarge the urinepassageway. The external control unit 10 releases energy carried by awireless signal and the implanted control unit 6 transforms the wirelessenergy into a current, for example a current, for powering themotor/pump unit 18 via an electric power supply line 24. The implantedcontrol unit 6 controls the motor/pump unit 16 and the restrictiondevice 4 via control lines 26 and 27.

FIG. 5 shows an embodiment of the invention comprising the restrictiondevice 4, hydraulically operated, and the implanted control unit 6, andfurther comprising a hydraulic fluid reservoir 230, a motor/pump unit232 and a reversing device in the form of a hydraulic valve shiftingdevice 234, all of which are implanted in the patient. The motor of themotor/pump unit 232 is an electric motor.

FIG. 6 shows an embodiment of the invention identical to that of FIG. 1,except that an accumulator 28 also is implanted in the patient. Thecontrol unit 6 stores energy received from the external control unit 10in the accumulator 28. In response to a control signal from the externalcontrol unit 10 the implanted control unit 6 releases energy from theaccumulator 28 via a power line 30 for the operation of the restrictiondevice 4.

FIG. 7 shows an embodiment of the invention comprising the restrictiondevice 4, hydraulically operated, and the implanted control unit 6, andfurther comprising a source of energy in the form of a battery 32, ahydraulic fluid reservoir 34, a motor/pump unit 36 and a reversingdevice in the form of a hydraulic valve shifting device 38, all of whichare implanted in the patient. The motor of the motor/pump unit 36 is anelectric motor. An external control unit 40 includes a wireless remotecontrol transmitting a control signal which is received by the signalreceiver incorporated in the implanted control unit 6.

In response to a control signal from the external control unit 40 theimplanted control unit 6 powers the motor/pump unit 36 with energy fromthe battery 32, whereby the motor/pump unit 36 distributes hydraulicfluid between the reservoir 34 and the restriction device 4. The controlunit 6 controls the shifting device 38 to shift the hydraulic fluid flowdirection between one direction in which the fluid is pumped by themotor/pump unit 36 from the reservoir 34 to the restriction device 4 torestrict the passageway, and another opposite direction in which thefluid is pumped by the motor/pump unit 36 back from the restrictiondevice 4 to the reservoir 34 to enlarge the bled flow passageway.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 6,except that a battery 42 is substituted for the accumulator 28, theexternal control unit 40 of the embodiment of FIG. 5 is substituted forthe external control unit 10 and an electric motor 44 is implanted inthe patient for operating the restriction device 4. In response to acontrol signal from the external control unit 40 the implanted controlunit 6 powers the motor 44 with energy from the battery 42, whereby themotor 44 operates the restriction device 4.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that the motor/pump unit 36 of the embodiment of FIG. 7 issubstituted for the motor 44 and a fluid reservoir 46 also is implantedin the patient. The reservoir 46 is via fluid conduits 48 and 50connected to the motor/pump unit 36 and restriction device 4, which inthis case is hydraulically operated. In response to a control signalfrom the external control unit 40, the implanted control unit 6 powersthe electric motor of the motor/pump unit 36 with energy from thebattery 42, whereby the motor/pump unit 36 distributes hydraulic fluidbetween the fluid reservoir 46 and the restriction device 4.

FIG. 10 shows an embodiment of the invention identical to that of FIG.8, except that a mechanical reversing device in the form of a gearbox 52also is implanted in the patient. The implanted control unit 6 controlsthe gearbox 52 to reverse the function performed by the restrictiondevice 4 (mechanically operated).

FIG. 11 shows an embodiment of the invention comprising the restrictiondevice 4, the external control unit 10, an implanted source of energy236 and an implanted switch 238. The switch 238 is operated by wirelessenergy released from the external source of energy of the externalcontrol unit 6 to switch between an of mode, in which the implantedsource of energy 236 is not in use, and an on mode, in which theimplanted source of energy 236 supplies energy for the operation of therestriction device 4.

FIG. 12 shows an embodiment of the invention identical to that of FIG.11, except that also the control unit 6 is implanted, in order toreceive a control signal from the wireless remote control of theexternal control unit 10. The switch 238 is operated by the wirelessenergy from the external source of energy 10 to switch between an offmode, in which the implanted source of energy 236 and the wirelessremote control of the external control unit 10 are not in use, i.e. thecontrol unit 6 is not capable of receiving the control signal, and astandby mode, in which the wireless remote control is permitted tocontrol the internal source of energy 236, via the implanted controlunit 6, to supply energy for the operation of the restriction device 4.

FIG. 13 shows an embodiment of the invention identical to that of FIG.12, except that an energy transforming device for transforming thewireless energy into storable energy is incorporated in the implantedcontrol unit 6 and that the implanted source of energy 236 is of a typethat is capable of storing the storable energy. In this case, inresponse to a control signal from the external control unit 10, theimplanted control unit 6 controls the switch 238 to switch from an offmode, in which the implanted source of energy 236 is not in use, to anon mode, in which the source of energy 36 supplies energy for theoperation of the restriction device 4.

FIG. 14 shows an embodiment of the invention identical to that of FIG.13, except that an energy storage device 240 also is implanted in thepatient for storing the storable energy transformed from the wirelessenergy by the transforming device of the control unit 6. In this case,the implanted control unit 6 controls the energy storage device 240 tooperate the switch 238 to switch between an off mode, in which theimplanted source of energy 236 is not in use, and an on mode, in whichthe implanted source of energy 236 supplies energy for the operation ofthe restriction device 4.

FIG. 15 shows an embodiment of the invention identical to that of FIG.13, except that a motor 242 and a mechanical reversing device in theform of a gearbox 244 also are implanted in the patient. The implantedcontrol unit 6 controls the gearbox 244 to reverse the functionperformed by the restriction device 4 (mechanically operated), i.e.enlarging and restricting the blood flow passageway.

FIG. 16 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communicationpossibilities. Basically, there are the implanted restriction device 4,the implanted control unit 6 and the external control unit 10 includingthe external source of energy and the wireless remote control. Asalready described above the remote control transmits a control signalgenerated by the external source of energy, and the control signal isreceived by a signal receiver incorporated in the implanted control unit6, whereby the control unit 6 controls the implanted restriction device4 in response to the control signal.

A sensor 54 may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the stomach. Thecontrol unit 6, or alternatively the external control unit 10, maycontrol the restriction device 4 in response to signals from the sensor54. A transceiver may be combined with the sensor 54 for sendinginformation on the sensed physical parameter to the external controlunit 10. The wireless remote control of the external control unit 10 maycomprise a signal transmitter or transceiver and the implanted controlunit 6 may comprise a signal receiver or transceiver. Alternatively, thewireless remote control of the external control unit 10 may comprise asignal receiver or transceiver and the implanted control unit 6 maycomprise a signal transmitter or transceiver. The above transceivers,transmitters and receivers may be used for sending information or datarelated to the restriction device from inside the patient's body to theoutside thereof.

The motor 44 may be implanted for operating the restriction device 4 andalso the battery 32 may be implanted for powering the motor 44. Thebattery 32 may be equipped with a transceiver for sending information onthe charge condition of the battery.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 1-15 could be combined in many different ways. Forexample, the energy operated switch 14 could be incorporated in any ofthe embodiments of FIGS. 4,6,8-10. The hydraulic shifting device 38could be incorporated in any of the embodiments of FIGS. 4 and 9. Thegearbox 52 could be incorporated in any of the embodiments of FIGS. 1,6and 8.

FIG. 17 illustrates how any of the above-described embodiments of theapparatus of the invention may be implanted in a patient. Thus, theapparatus comprises a restriction device 56 implanted in the patient andengaging the penile tissue 58, and an operation device 60 for operatingthe restriction device 56. A control device in the form of a wirelessremote control comprises an implanted control unit 62, which includes asignal receiver, for controlling the operation device 60, and anexternal control unit 64 including a signal transmitter for transmittinga control signal to the signal receiver of the implanted control unit62. The implanted control unit 62 is capable of transforming signalenergy from the control signal into electric energy for powering theoperation device 60 and for energizing electric energy consumingimplanted components of the apparatus.

FIG. 18 shows the basic parts of a wireless remote control of theapparatus of the invention including an electric motor 128 for operatinga restriction device, for example of the type illustrated in FIG. 17. Inthis case, the remote control is based on the transmission ofelectromagnetic wave signals, often of high frequencies in the order of100 kHz-1 gHz, through the skin 130 of the patient. In FIG. 18, allparts placed to the left of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises aapproximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same restriction as the coil of the receiving antenna134 but wound with a thick wire that can handle the larger currents thatis necessary. The coil of the transmitting antenna 132 is tuned to thesame specific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to activate therestriction device to either restrict or enlarge the blood flowpassageway. The microprocessor starts a command by applying a highfrequency signal on the antenna 132. After a short time, when the signalhas energized the implanted parts of the control system, commands aresent to restrict or enlarge the blood flow passageway in predefinedsteps. The commands are sent as digital packets in the form illustratedbelow.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new restrict or enlarge step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energizer unit 126 draws energy fromthe high frequency electromagnetic wave signals received by thereceiving antenna 134. The energizer unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 andpowers the electric motor 128 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergizer unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 128 to operate the restriction device toeither restrict or enlarge the blood flow passageway depending on thereceived command code.

Alternatively, the energy stored in the power supply of the energizerunit may only be used for powering a switch, and the energy for poweringthe motor 128 may be obtained from another implanted power source ofrelatively high capacity, for example a battery. In this case the switchis adapted to connect the battery to the control unit 138 in an on modewhen the switch is powered by the power supply and to keep the batterydisconnected from the control unit in a standby mode when the switch isunpowered.

With reference to FIG. 15, the remote control schematically describedabove will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theapparatus. The power amplifier 150 amplifies the signals and sends themto the external signal transmitting antenna 132. The antenna 132 isconnected in parallel with a capacitor 152 to form a resonant circuittuned to the frequency generated by the signal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 168 connected in series with aresistor 170 connected in series with a capacitor 172 connected inseries with the resistor 168 via ground, and a capacitor 174, oneterminal of which is connected between the resistors 168,170 and theother terminal of which is connected between the diode 166 and thecircuit formed by the capacitor 162 and resistor 164. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 176 thatdecodes the digital information and controls the motor 128 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 128can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 128,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor128.

1. A male sexual impotence treatment apparatus, comprising an operablerestriction device implantable in a patient for engaging the peniletissue or the prolongation thereof to form a restricted blood flowpassageway through which blood flow leaves the penis, the restrictiondevice being operable to restrict the blood flow passageway to provideerection, characterised in that a source of energy is provided, and acontrol device operable from ‘outside the patient's body is provided forcontrolling the source of energy to release energy for use in connectionwith the operation of the restriction device, when the restrictiondevice is implanted.
 2. The apparatus according to claim 1, wherein thesource of energy is intended to be external to the patient's body, andthe control device is adapted to control the external source of energyto release wireless energy for use in connection with the operation ofthe restriction device.
 3. The apparatus according to claim 1, whereinthe control device controls the restriction device.
 4. The apparatusaccording to claim 3, wherein the control device comprises an internalcontrol unit implantable in the patient for controlling the restrictiondevice.
 5. The apparatus according to claim 4, wherein the internalcontrol unit is programmable.
 6. The apparatus according to claim 5,wherein the control device comprises an external control unit intendedto be outside the patient's body, the internal control with beingprogrammable by the external control unit.
 7. The apparatus according toclaim 5, wherein the internal control unit is programmable forcontrolling the restriction device over time.
 8. The apparatus accordingto claim 7, wherein the internal control unit controls the restrictiondevice over time in accordance with an activity schedule program.
 9. Theapparatus according to claim 7, wherein the internal control unitcomprises a microprocessor.
 10. The apparatus according to claim 6,wherein the external control unit loads the internal control unit withdata in accordance with a loading mode only authorized for a doctor. 11.The apparatus according to claim 6, wherein the external control-unitcontrols the internal control unit in accordance with a doctor mode onlyauthorized for a doctor.
 12. The apparatus according to claim 6, whereinthe external control unit controls the internal control unit inaccordance with a patient mode permitted for the patient.
 13. Theapparatus according to claim 1, wherein the source of energy isimplantable in the patient.
 14. The apparatus according to claim 13,wherein the implantable source of energy comprises at least oneaccumulator, at least one capacitor or at least one rechargeablebattery, or a combination of at least one capacitor and at least onerechargeable battery.
 15. The apparatus according to claim 14, whereinthe implantable source of energy comprises an electric source of energy.16. The apparatus according to claim 15, wherein the electric source ofenergy comprises an accumulator, or a battery having a lifetime of atleast 10 years.
 17. The apparatus according to claim 1, wherein thecontrol device controls the restriction device.
 18. The apparatusaccording to claim 2, further comprising an energy storage deviceimplantable in the patient for storing the wireless energy released fromthe external source of energy.
 19. The apparatus according to claim 18,wherein the energy storage device comprises an accumulator.
 20. Theapparatus according to claim 19, wherein the accumulator comprises anelectric accumulator. 21.-145. (canceled)